[I have borrowed somewhat from my prior blog posts and my legal complaints for this piece, but I’ve added on, so to speak, based on recent events and I thought it might be helpful to have all the arguments in one place, at least those that I could think of. Additional arguments are most welcome in the comment section.]

Like many patients, I crashed badly after that CFSAC “webinar” from hell last month, which forced me to be MIA for a while. I’ve got lots to say about that “meeting” and its many irregularities, but I’ll save that for my next blog post. In the meantime, I thought it might be helpful to summarize why the “study” by the Institute of Medicine (IOM) remains a frightening prospect for ME patients and why it is crucial to continue our opposition to it. After all, the relentless government propaganda on the alleged blessing that is the IOM—either directly by HHS or through its surrogates—is designed to make the most resolved patient feel defeated. Here is why the IOM “study” is indeed bad news for patients, why this saga is far from over and why being resigned only plays into the hands of those determined to bury us: HHS and the insurance companies.

Not a “done deal.” Let’s start with the most ridiculous argument the other side keeps trying to brainwash us with, the “done-deal” talking point. We recently heard it again from Dr. Nancy Lee at the December 2013 CFSAC “meeting” at which she called the IOM contract, in a rather irritated manner, an “irrevocable contract.” She stated firmly that the money, $1 million, cannot be recovered from the IOM by HHS because the agency used year-end money for the IOM contract.

I’ll talk more about this in my next blog post, but let me preface the following comments with my sincere assurance that they are not intended as a personal attack on Dr. Lee. Advocacy is political discourse and, like it or not, the government’s spokespeople don’t get to whine about taxpayers’ voicing their opinions when when their agency is doing a hack job or, worse, potentially misinforming the public, intentionally or not. This is especially true in the context of a patient population that has been ridiculed, short-changed, neglected, harmed, dismissed and thrown to the wolves by the government for decades. This is obvious to most people, but apparently not to all. I am not naive enough to think that Dr. Lee is the only player in this horrific game. There are other folks involved here who are likely much higher up in the HHS hierarchy. However, Dr. Lee accepted the task of attempting to placate the patient community.

Legally, the concept of revocation—the unilateral withdrawal of an accepted offer—does not even come into play here. Nobody is asking to have the contract (an accepted offer) revoked, a mechanism that is not provided for by the law when it comes to contracts. Patients are asking that the contract be terminated by the government. Maybe Dr. Lee thought that using a big term, such as “irrevocable,” would be more intimidating. (Sense a pattern here?) Or maybe Dr. Lee wasn’t briefed (sufficiently) by HHS’ legal department. Either way, her statement is not sensible legally.

I don’t know if Dr. Lee has been legally trained, so let’s give her the benefit of the doubt and assume that she meant that the contract cannot be terminated. The veracity of such statement is highly questionable. As has been pointed out in this context by others many times, government contracts can pretty much always be terminated for the convenience of the government, i.e., for any or no reason.

[t]he contracting officer shall insert the clause at [48 CFR] 52.249-4, Termination for Convenience of the Government (Services) (Short Form), in solicitations and contracts for services, regardless of value, when a fixed-price contract is contemplated and the contracting officer determines that because of the kind of services required, the successful offeror will not incur substantial charges in preparation for and in carrying out the contract, and would, if terminated for the convenience of the Government, limit termination settlement charges to services rendered before the date of termination.

In other words, HHS would, under federal regulations, have been required to include the following termination-for-convenience clause in the IOM contract (from 48 CFR 52.249-4):

Termination for Convenience of the Government (Services) (Short Form) (APR 1984). The Contracting Officer, by written notice, may terminate this contract, in whole or in part, when it is in the Government’s interest. If this contract is terminated, the Government shall be liable only for payment under the payment provisions of this contract for services rendered before the effective date of termination.

Therefore, based on federal regulations, the termination for convenience by HHS of the IOM contract merely requires the government’s paying to the National Academy of Sciences (who sub-contracted with the IOM) for the services rendered and expenses incurred prior to the termination (plus possibly a reasonable profit on the work already performed). In this case, the IOM committee members have not even been appointed yet. So the amount owed by HHS is probably minimal; I would be very surprised if it exceeded $50,000. Even if it does, do we want to accept a botched definition affecting the lives of hundreds of thousands of patients and their families most likely for decades merely in order to justify the expenditure of a relatively small amount of taxpayer money compared to the cost to the U.S. economy in the tens of billions every year? I know I don’t. No reasonable person would.

Even if the recovered money won’t be re-allocated to HHS’ budget, it’s not like the IOM would get to keep it. It will go back to Treasury, and, thus, the taxpayers. And maybe HHS can re-direct the money to other IOM-related tasks, such as fixing the defective Gulf War Illness (GWI) report(s) by, at a minimum, reversing the name change from Gulf War Illness to the outrageous name Chronic Multi-Symptom Illness and by clarifying that antidepressants, cognitive behavioral therapy (CBT) and graded-exercise therapy (GET) are inadequate band aids at best, not treatments of the underlying serious disease.

[*Of course, we cannot be entirely sure what the IOM contract provides for—maybe it’s in violation of the federal regulations—since it has not been made available to the public despite at least three Freedom-of-Information-Act requests by patients. More about that below.]

As I’ve said before, you’ve got to think of this whole thing as a psych op. It has been psychological warfare from the beginning: talking points of questionable accuracy disseminated by the government and its allies designed to make patients feel powerless, full-court press to push this “study” through without any accommodation of the patient community’s or CFSAC’s concerns, complete secrecy and potential misleading of the public, etc. I know the situation is scary because if the IOM study goes through, ME patients are sunk. So, the stakes are high. But don’t be fooled into thinking that we are powerless just because that’s what the government is trying to make us believe. We are anything but. There have been a number of indications that HHS is quite nervous about the patients’ strong and unparalleled opposition to the IOM. For example, do you really think there would not be more mental-health professionals on the panel, similar to the last GWI IOM committee, without all the patient pressure? In fact, do you really believe there would be any ME experts on the committee without our opposition? HHS has flinched. Let’s keep that pressure on. We’ve got absolutely nothing to lose by resisting all the way (as opposed to cooperating) because the sham input we are given is a transparent ploy.

Who wants to bet that the comments that patients submitted regarding the “provisional” IOM committee members will lead to absolutely zero change in the committee’s membership? I understand and respect why patients provided feedback. It’s the desperate hope of influencing the outcome of this frightening process. But, in my opinion, such cooperation will only give HHS cover in claiming that patients were heard and included in the process when, in reality, it’s a set-up and it won’t work, which leaves us with one option only: continuing our uncompromising complete resistance. It’s not hard to imagine the content of the final report. Just look at the IOM’s reports on GWI. That’s what our report will look like. For example, exercise was mentioned as a treatment for “ME/CFS.” So, if exercise helps, then clearly, exercise intolerance or post-exertional malaise, the hallmark feature of “ME,” can logically not be part of the definition.

There will be no influencing of this train wreck by patients through cooperation. No changes will be made to help us get our desired outcome. Any changes the IOM might make to pacify us are most likely merely cosmetic. But let’s assume for a minute, for argument’s sake, that some of the particularly worrisome provisional committee members will be replaced based on the public’s feedback. Then HHS would have a strong argument in asserting that patients have been accommodated, except that there is a snowball’s chance in hell that ME experts would be placed on the committee instead. What would be gained for patients by exchanging one non-expert for another? Of course, in reality, every committee member who is not an ME expert is unacceptable, not just those that seem to stand out like a sore thumb as being biased and especially unfit to serve on the committee.

Think about it! If the IOM really wanted our input, would it have set a December 23 deadline for feedback, right before a major holiday? Of course not. The fact that it did so is a dead give-away. There is not even an attempt at pretense that the patients’ degree of disability is taken into account. After a grossly mishandled and, thus, for patients, extremely draining CFSAC “meeting,” public comments for which were due the day after Thanksgiving, patients barely had time to recover for the committee-comments deadline and then crashed again right before Christmas. Scheduling these important deadlines close to holidays is either intentionally cruel or frighteningly ignorant. Either way, it doesn’t give me any comfort as to the outcome of the “study.” All that lip service about how much HHS cares! Patients are cognitively impaired, but not to a degree that complete contempt and total lack of respect and consideration would go unnoticed. In any event, had I recovered in time to have the cognitive wherewithal by the deadline, my comment would have been, “I object to the IOM “study” because the IOM is, by its own admission, not qualified to perform the contracted-for task and because it has an institutional conflict of interest.” Full stop. No engaging on particular panel members because the IOM itself and all non-experts are unqualified and/or biased.

Some patients have been taken in by the “done-deal” argument; they feel that any opposition to the IOM contract is likely futile. I respectfully disagree. This is an 18-months “study.” With an effective date of September 23, 2013, we are very early in this process. As I said, the committee members haven’t even been appointed yet. This is like calling a nine-inning baseball game as soon as the first batter is on deck. So many things can happen here. The media could pick up this incredible saga. Numerous journalists are currently researching, and interviewing patients and experts for, this story of a majority of non-experts defining the potentially most complex disease of our time. One or more ME experts on the panel may resign in a vocal manner due to moral concerns. That government employee might just be getting close to blowing the whistle on potential HHS misconduct. We might find out that the contract has a serious, maybe fatal, defect. Legal avenues are being evaluated by a good number of patients working with lawyers because there clearly seems to be something fishy going on with respect to this contract. Patients are actively engaged with Congress on this issue and are pushing for a Congressional investigation. Sizable demonstrations are being planned. Until the final IOM report is published—which, if the majority of patients has anything to say about it, will never happen—this deal is not done by a long shot.

The IOM “study” is contrary to CFSAC’s October 2012 recommendation. At its meeting in October 2012, CFSAC, following considerable discussion and analysis, recommended the following to the Secretary:

CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS) experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes.

So, what was recommended was to hold a stakeholders’ meeting—in consultation with CFSAC members—with ME/CFS experts, patients and advocates to reach consensus on a case definition based on the Canadian Consensus Criteria (CCC). Instead what did we get? A “study” by the IOM that includes no patients or advocates nor CFSAC, but instead involves a majority of eight professionals without any prior experience with ME/CFS versus a minority of seven ME/CFS experts, as admitted by HHS through Dr. Lee during the last CFSASC meeting. Everybody who watched that October 2012 CFSAC meeting was quite clear that the recommendation referred to ME/CFS experts. For good reason. Would you trust a heart surgeon, maybe even the world’s foremost one, with your potentially fatal brain surgery? Of course not. This not only makes no sense, but it’s also contrary to the obvious intent of the CFSAC recommendation as it relates to the involvement of professionals with ME/CFS expertise only. The IOM “study” is quite obviously not what CFSAC recommended. It is actually the exact opposite.

In a letter by Secretary Sebelius to our experts, she claims that the IOM study was necessary because “HHS does not generally develop diagnostic criteria for disease conditions.” If anybody ever needs an example of somebody insulting others’ intelligence, this one is as perfect as it gets. I mean, really!? We have been harmed for almost 20 years by the Fukuda definition developed and adopted by … wait for it … the CDC! We may be cognitively impaired, but people within and outside the patient community can see right through this complete lack of even a hint of sincerity in the Secretary’s letter.

It’s one thing for the Secretary to disregard a recommendation; CFSAC is used to that. But to hijack it for purposes clearly contrary to CFSAC’s intent, that’s taking it to a different level entirely. It’s adding major insult to injury. There seems to be no concern on the part of HHS about having dropped the pretense that CFSAC is an independent and respected advisor to HHS. This is how badly the government wants this “study.”

In responding to CFSAC member, Eileen Holderman, at the December 2013 CFSAC meeting, Dr. Lee informed us that, among the CFSAC membes, only Dr. Gailen Marshall, CFSAC’s chair, and CFSAC’s ex-officio members were involved in the development of the statement of work while, at the same time, explaining that only federal “people” can be involved in the contracting process. That begs the question of the justification of Dr. Marshall’s involvement.

According to three CFSAC members, Ms. Holderman, Mr. Steve Krafchick and Dr. Mary Ann Fletcher, the ten other CFSAC voting members (other than Dr. Marshall) had no input in, or knowledge of, the IOM process until the contract was signed. Ms. Holderman stated for the record that CFSAC’s recommendation was ignored and not implemented. She called for the termination of the IOM contract and the adoption of the CCC because the majority of stakeholders reject the IOM “study.” Dr. Lee’s response to that was that CFSAC is an advisory committee, not an oversight committee. In other words: “Buzz off!” She then stated, “We took the advice and we put it through our public-health experience.” I believe that is code for giving the powers that be within HHS that are intent on burying or trivializing the disease the opportunity to closely control the process.

The IOM “study” is contrary to the experts’ clear opposition to it. Remember, 50 ME/CFS experts remain opposed to this “study” and warned specifically that a “study,” such as the one to be undertaken by the IOM, “threatens to move ME/CFS science backwards by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”

The open experts’ letter to the Secretary also urges the adoption of the CCC. The experts decided that the CCC—reflecting about 400 years of clinical and teaching experience, hundreds of peer-reviewed publications and about 50,000 ME cases—are more than good enough. HHS has always said that a definition must originate within the medical community. Well, the CCC did and the experts called the Secretary’s bluff. Are the CCC perfect? No, but they are a very sophisticated starting point and a quantum-leap improvement over Fukuda and the experts have already committed to refining it over time.

Secrecy: big red flag. HHS officially first announced its intent to contract with the IOM in a no-bid, sole source solicitation on August 27, 2013. One week later, on September 4, 2013, HHS stated, “Because of all the concern from the public surrounding the sole source solicitation, we have decided to discontinue this request.” Less than three weeks later, on September 23, 2013, HHS announced that it had, in total secrecy, entered into the contract with IOM. Makes you wonder whatever happened to the issue of “the public concern” because that certainly hadn’t and still hasn’t been resolved. So, I can’t help but feel that HHS pulled the solicitation to finalize the contract in secret, thereby preventing any chance of the public to mount any opposition. I think the expression for this is “pulling a fast one.”

But wait! It gets worse. At least three patients (Ms. Patricia Carter, Ms. Jennie Spotila and myself) have asked for copies of the contract under the Freedom of Information Act shortly after it was signed. But, to my knowledge, none of the requests have been honored within the 20-business-day deadline, which in my case was November 25, 2013, more than a month ago. I know for a fact that Ms. Carter hasn’t received the contract and neither have I. I don’t know about Ms. Spotila, but since she hasn’t posted it, I doubt she has a copy. As my husband, Ed, put it, “If HHS has nothing to hide, why put sick patients through the time and effort required to put together such an FOIA request?” It’s unconscionable. Ed continued, “This stonewalling and lack of transparency by HHS, along with the rush in finalizing this contract, raise serious questions about the contracting process [and I will add: the contract terms] itself.”

If you think about it, if you are HHS and you are trying to get patients on board—because they so obviously aren’t—wouldn’t you opt for as much transparency as possible? Oh right! That would require that HHS actually care about what patients think. Silly me!

The Secretary, in her letter to the experts, assured them of HHS’s commitment to fostering open dialog. This is nothing short of gag producing given the secrecy and manufactured urgency as well as the tardiness in “replying” to the experts and the complete ignoring of the advocates. Open dialog? HHS has not even produced the contract yet despite being legally obligated to under federal law. And if an open dialog is so desired by HHS, why not reply in kind, with an open letter, to the experts?

Urgency: big red flag. One of the $1 million questions is the reason for the extreme speed at which this study is forced down our throats. After all—in cases other than national-health crises, like a threat to the blood supply—this kind of urgency is highly unusual, if not completely unprecedented.

Potential non-compliance with competition rules. Furthermore, HHS seems to have entered into the contract without complying with federal-contract acquisition requirements applicable to a no-bid contract. I filed two complaints regarding this potential violation, one with the Inspector General (radio silence despite my following up) and one with HHS’ Competition Advocate. The latter forwarded my request for investigation to HHS’ legal department.

Institutional conflict of interest. As I pointed out in my requests for investigation with the Inspector General and the Competition Advocate, the IOM has a clear and blatant institutional conflict of interest with respect to this contract, which conflict-of-interest checks of the panel members can’t cure.

Throughout the recent GWI report, the IOM references ME/CFS and, in particular, its case definition, symptoms and treatment modalities. These are all used as critical building blocks in reaching the IOM’s conclusion regarding treatment of GWI. The case definition and symptoms and possibly treatments of “ME/CFS” are at the heart of the IOM contract. The conflict here is obvious. The IOM is wedded to the GWI report’s conclusions from just earlier this year that is based, in part, on its assumptions and conclusions about “ME/CFS.” That represents a substantial bias in favor of not contradicting its prior assumptions and findings and prejudices the IOM against adopting findings that are inconsistent with the GWI report.

When you also take into account the tremendous backlash the recent IOM report has triggered in the GWI population, it becomes even more obvious that the IOM cannot afford to backtrack on any of its previous findings regarding “ME/CFS” because the GWI report rests largely on those. The GWI report triggered Congressional hearings and serious accusations of the report being tainted due to an undue influence on the report by the Department of Veterans Affairs. A high-level government epidemiologist, Steve Coughlin of the VA, went public with criminal allegations under the Whistleblower Protection Act.

Do you think it is likely that a panel composed on mostly non-ME/CFS experts and several IOM “regulars,” including the committee chair, will abandon these conclusions regarding “ME/CFS” and undermine the findings of the GWI report? Not a chance since that would give its detractors more ammunition for invalidating that report. Consider the embarrassment and potentially even serious legal consequences for the IOM and/or HHS. It’s just not going to happen.

The GWI report from earlier this year clearly stated on page viii, “Responsibility for the final content of the report rests entirely with the authoring committee and the institution.” (Emphasis added.) The IOM expressly endorsed the report and cannot credibly claim now that only the GWI committee took ownership of it. It specifically stated otherwise in the report.

Based on prior precedent laid out in my first call for investigation with the Inspector General, this situation creates an institutional conflict of interest, i.e., a bias of the entire institution of the IOM. Notice that neither HHS nor the IOM has addressed this issue! Instead they keep referring to conflict-of-interest checks of the panel members, which is completely non-responsive to the serious concern of the bigger, organizational conflict.

The committee: amateur hour. I mean no offense to some of our more esteemed experts who were nominated, but the concept of convening a committee with any non-experts, let alone with a majority of non-experts, is nothing short of ludicrous. It’s insanity that is not even in the realm of reasonableness. The rationale reportedly given by the IOM, i.e., that the definition “will be used by physicians/clinicians with and without experience in ME/CFS, so the participation of committee members from both perspectives is very important” is mind-boggling. In no other area of any significance or in any complex field would the definition of a crucial issue, such as a disease definition, be turned over to non-experts. It’s unthinkable and would be ridiculed to no end.

This is like tasking a group of tax lawyers with the development of trademark law because, you know, one day, a non-trademark lawyer’s client might have a trademark question. To give the non-experts the ability to develop the diagnostic criteria through a secret majority vote is absurd and puts the “ME/CFS” patient community at serious risk.

Definitions are not diseases, they are often simply the best descriptions that physicians and researchers can offer, with their always imperfect knowledge, to describe a disease. Good definitions are good because they correspond closely to the disease state being described. It is thus important that those that attempt to define any disease or illness … have long term clinical experience with patients with this illness. There is simply no place for the bureaucrat in defining illness. All definition of epidemic or infectious illness must be based upon persistent clinical examination of the afflicted patient, an understanding and exploration of the environmental factors producing that illness, and pathophysiological examination of tissue from those patients. For similar reasons, I believe that the inclusion of psychiatrists in the defining of an epidemic and obviously disease of infectious origin, simply muddies the water for any serious understanding of that disease. (Emphasis added.)

(Hat tip to Danny Ze-dog for this find.)

At the last CFSAC “meeting,” various CFSAC members, including Ms. Holderman, raised their serious concern about non-experts being involved in defining this disease. Mr. Krafchick, who made the October 2012 motion resulting in the CFSAC recommendation to the Secretary, and Dr. Fletcher made it clear that the recommendation made by CFSAC related to a consensus workshop with experts in the community and that it wasn’t intended that professionals outside “of the field [would be] given the task of revising a good definition, the CCC.” Dr. Fletcher flat out stated, “I am really not happy with this.”

Evidence-based approach leading to disastrous criteria. Another tip of the hat for some of the following points to Danny Ze-dog: One argument by HHS is that the CCC are ten years old and don’t reflect the latest research. However, one problem with the IOM, and any evidence-based approach towards ME, is that there has been almost no funding for replication studies of biological findings, but plenty for repetitions of CBT and GET trials, so the ‘evidence base’ is skewed towards the psychological dimension. You know who likes evidence-based approaches? Insurance companies. And if that doesn’t scare you, then I don’t know what will.

A not well understood disease can only be defined by experts in the field based on their total clinical knowledge, most of which is NOT published. For that reason alone, they should be the ones defining the disease.

What do you think the odds are that this panel can agree on a definition at least as accurate as the CCC? Even if the CCC become the starting point for the experts, they are in the minority and, therefore, will have to compromise FROM that position. Are patient advocates and experts really willing to accept a process that, even if our side fights its hardest, is likely to result in a definition weaker than the CCC?

So, while HHS’ argument is that the IOM can do better than the CCC, the reality is that it is bound to do worse. Much worse. At the last CFSAC meeting, both Mr. Krafchick and Dr. Fletcher emphasized that the the-CCC-is-ten-years-old argument by HHS is a red herring. After all, 50 ME/CFS experts agree that the CCC are the appropriate case definition to adopt. Clearly, the experts know better than the government, which remains mostly ignorant or dismissive about the disease. During the CFSAC meeting, Mr. Krafchick called the CCC “alive and well.” And Dr. Fletcher confirmed that the experts are, of course, open to examining and updating the CCC.

Dr. Lee stressed her excitement about the possibility of the IOM-generated diagnostic criteria being published as a lead article in the Journal of the American Medicine Association, JAMA, in a couple of years. Talk about a nightmare for ME patients: antidepressants, CBT and GET endorsed by one of the leading medical journals of the country. Farewell antivirals, immune-modulators, aminos, etc.

Secret meetings. Keep in mind that, once the panel is finalized and the “study” proceeds, it will largely be conducted in secret. The statement of work calls for only one public meeting, and there is no requirement that the panel respond publicly to any concerns or issues raised at this meeting. The final meeting to reach consensus on the report and the review of that report will all be secret.

Especially if you’ve got a majority of professionals who are largely, if not completely, ignorant about a very complex disease whose fate they are about to decide, it is crucial to have the scrutiny of non-panel ME/CFS experts and the public. Private meetings permit the minority of ME experts to be marginalized without transparency. Given the IOM’s track record, this should set off very loud alarm bells.

What are they “studying” anyway? Without going into depth on the issue because it is beyond the scope of this post, let me just mention that studying two completely different disease entities, ME and CFS, together, is as unscientific as it gets. ME is not CFS and vice versa. The name Chronic Fatigue Syndrome was deliberately chosen by the CDC to muddy the waters because it can be, and is, used interchangeably with fatiguing conditions, such as deconditioning, psychological diseases, such as depression, as well as conditions that are not even illnesses, but produce fatigue as a symptom.

Many patients do not understand the difference between ME and CFS because the government has done a good job at creating confusing around the two. Even some experts do not keep them separate. Worse, they use the dreaded term “chronic fatigue” for ME all the time, a source of never-ending frustration for patients suffering form the debilitating effects of ME. Some experts openly admit that they are treating people fatigued due to medical conditions other than ME or due to mere deconditioning. With an unscientific status quo like that, how could the non-experts on the panel possibly understand the distinction? It’s just not conceivable that a decent, scientifically accurate definition of ME could be produced by this particular IOM committee.

As if to confirm the point, the IOM, via its listserv, announced that the first IOM meeting will be held on January 27-28, 2014 during which one objective for the committee is “to clarify the scope of the charge ….” In other words, the IOM is unclear about what it got hired to do, which is outrageously pathetic and mind-blowingly unprofessional. So the IOM is wondering what the heck they are going to be paid the sum of $1 million for. I might be cognitively impaired, but I am quite certain that I have never advised a client to enter into a contract with an uncertain scope.

How does one even pick a panel for the “study” without knowing what the panel will be doing? Seriously, this is not a rhetorical question.

Intimidation by the government. Dr. Lee stated, at the last CFSAC meeting, in a quite patronizing manner, that nobody on the IOM staff or a committee member has any bad intentions and that suggestions to the contrary “could backfire” on the patient population. Excuse me, but this is not a grade-school soccer game where mere attendance is rewarded and everybody receives a trophy regardless of performance. This is about the lives of severely ill patients. Not being hostile, even trying hard, isn’t good enough. This is about competence, which can only come from experience with the relevant subject matter, and fitness to get the job done well. That is what’s being questioned by patients. Not having ill intentions is a ridiculously and unacceptably low standard by HHS and I am puzzled by the fact that Dr. Lee felt comfortable admitting to that.

What’s more alarming about Dr. Lee’s statement, however, is the fact that it was a thinly veiled threat during a public-comment period regarding the provisional committee members. Insinuating that unfavorable public opinion will be detrimental to patients is like a police officer abusing his or her discretion by giving a ticket to a motorist just because the driver argued the justification of the citation. “I was gonna let it slide, but since you talked back, I will give you that ticket. There! That’s how much power I have and I am not afraid to abuse it.” It’s a disturbing and potentially illegal abuse of power.

Attempted intimidation of the public by a government official has a chilling effect on free speech. One has to wonder if the fact that Assistant Secretary, Dr. Howard Koh, basically blew off serious allegations by two (correction: three) CFSAC members of Dr. Lee’s intimidation tactics (and thereby endorsed them)—by dismissing the charges without any meaningful response—made Dr. Lee feel omnipotent and untouchable. If Dr. Lee is this comfortable threatening patients in public with consequences of their speaking out—and she made other alarming comments at the CFSAC meeting, which I will address in my next blog post—just imagine what she might have said in private to those CFSAC members! It seems to me that she lent a whole lot more credibility to the complaining CFSAC members, not that their integrity was in question before. This is the potential disturbing pattern I alluded to above.

Bottom Line. To suggest, as the Secretary has done, that an IOM “study” is in the best interest of the patients, after the IOM threw veterans—a group of citizens that pretty much everybody is supportive of, even those folks who are against the wars—under the bus is at best disingenuous. Personally, I find it insulting. If the IOM has no sleepless nights over the IOM GWI fiasco, what do you think they will do to patients who have historically been neglected, abused and labeled as lazies crazies by the government, the medical establishment and the insurance companies in part due to the government’s woefully inadequate Fukuda definition?

I have been asked if I am 100% sure that the IOM outcome will be bad? Well, no, I am not. But I am also not 100% sure that I’d be killed if I jumped off the Golden Gate Bridge, yet I don’t plan on jumping to test the hypothesis.

I have also been asked what my ultimate goal is in fighting the IOM contract. This is like asking somebody who is trying to stop nuclear war what he or she will do afterwards to end world hunger. We don’t have to worry about what happens after an IOM “study” because it would be the end of the road for patients and science if it proceeds. If we lose this battle, we will have lost the war for decades to come, maybe forever.

However, it’s not like the experts in their open letter to the Secretary only opposed an IOM-like effort to develop yet another flawed government-sponsored definition without suggesting how to proceed without the IOM. Instead, they offered a path forward by urging HHS to adopt the CCC, like they themselves have, as the clinical and research definition and once that occurs, we will see a surge in much more scientifically-accurate research of the disease that is based on clearly defined cohorts meeting accurate criteria for the disease and no more research of tired people. Of course, even though the CCC are a very strong case definition as is, the experts would refine it. That’s what frequently happens with other case definitions. So, the experts have, in their open letter, clearly laid out a plan and it’s disingenuous to suggest that they are merely saying no the IOM.

Even if you think that an IOM report on “ME/CFS” is inevitable, which is merely a government talking point, what do you think will motivate the IOM committee members more to do right by ME patients: (1) keeping the pressure on and continuing to create a real risk that that the IOM “study” will be stopped altogether or completely discredited by one of the means mentioned above, which would not look so good on any of the committee member’s resume or (2) conceding that the “study” will proceed and, thus, surrendering any leverage? It’s a no-brainer, don’t you think? Seriously, let’s not give up our power by capitulating!

If the government really had a change of heart, it has a hell of a way of showing it. Like a battered spouse, some patients have gone back for more, over and over for decades, all the while hoping that this time, it would be different. And as in abusive relationships, the abuse has gotten worse and worse. Just look at the last CFSAC “meeting.” Remember Albert Einstein’s definition of insanity: “Doing the same thing over and over again and expecting different results?” Most ME patients who are involved in any kind of advocacy or raising awareness are very informed, proactive and engaged and they do understand that we have nothing good to expect from HHS. Any excuse being made by a minority of patients for HHS’ open contempt for the ME community can only be explained by a bad case of Stockholm Syndrome. Instead of listening to the majority of patients who is telling the government that it doesn’t want yet another harmful government-sponsored disease definition, HHS sadly takes full advantage of a small minority of the patient population who seems less informed or maybe overly trusting by trying get them to cooperate and comply, be spokespeople or give them a seat at the table.

Thank you, Jeannette, for another honest and insightful article. You’ve made so many important points. This is worth reading more than once. Our health and our futures ARE at stake.

Thank you also to Jennie, Patricia, Erica and all of the advocates who keep fighting this fight for us!

I’m wondering, is there any recourse when an FOIA request goes unacknowledged? I’m not a suspicious person by nature, but when three requests are dishonored, it makes one wonder if there’s something they’d rather we not see or share.

All I can say after reading this article is BRAVA, Jeannette! This is an excellent analysis of the situation and you have articulated it in such a way that anyone (even government bureaucrats) should be able to understand. Thank you, Jeannette.

Welcome back :) and thank you, Jeannette, for laying out the collective sequence and series of events surrounding the contracting of IoM to redefine ME/CFS.

It is MORE than obvious, in action after action, INaction and REaction, that there is a BULLYING DECEITFUL MINDSET and MOVEMENT AGAINST pw ME/CFS; MILLIONS of us world-wide–an UNtoward effort AGAINST getting to the biological scientific answers of ME/CFS. Ummmm–how about the HHS’ BLATANT DISREGARD of the ME/CFS EXPERTS AND RESEARCHERS when they voiced their concerns in an OPEN letter to Sebelius. OUTRIGHT DISMISSAL OF EXPERTS AND RESEARCHERS in the field of ME/CFS; doesn’t that make your head shake–LUDICROUS behaviour on behalf of Sebelius and the Department of Health and Human Services, and in her /their DIRECT representation of the ENTIRE US government.

Absolutely–first and foremost the IoM itself is in a conflict of interest in entering into this contract. Then the panel–‘INSANITY’ as to how it is set up — conveniently, that insanity equals to the predetermined outcome expectations in ‘setting up’ the ‘unidentified contract’ with IoM.

There are HUGE interests–insurance companies, politics and egoes–involved in this despicable MOVEMENT AGAINST pw ME/CFS–‘they’ are amping up their MO with the ABSURD FARCICAL IoM contract. It IS UNconscionable that this movement AGAINST pw ME/CFS is being put out to hire and that there is such a movement AGAINST us at all. MORE INSANITY!!!

Something I came across recently in viewing this link in the Huffington Post (11/20/2013) entitled The Most Prevalent and Devastating Disease Your Doctor Has Ever Heard Of (Jennifer Brea)–in the comments section–(in reloading to the next 10 comments)–posting by Justin Reilly on November 21, 2013. A breakdown on the credentials of the IoM panel re the GWI redefinition is given listing MANY ‘interesting’ points.http://www.huffingtonpost.com/jennifer-brea/myalgic-encephalomyelitis_b_4303725.html

In this post, the point below was something I was previously UNaware of and really captured my attention–i.e. the chair of the IoM panel (GWI) — A DIRECTOR OF UNITED-HEALTH INSURANCE . . .
“1 (6% of committee), the chair of the panel, Dr. Shine, is both a Director of UnitedHealth Insurance (undisclosed in bio) and a past President of IoM.”

Talk about a PREDETERMINED OUTCOME to the DETRIMENT of the VETERANS. AND MOST IMPORTANTLY–WHO IS CALLING FOR — and WHO IS ALLOWING THIS ?? AND–WHEN will they be BROUGHT TO CHARGE / JUSTICE ??

Yesss, Stockholm Syndrome–stuck in the pattern of behaviour / abuse by the abuser; ‘must not speak up for fear of a worse situation / angering the abuser’ . . . OPPRESSION OF VICTIMS–THE ILL. (Therefore, we must) Trust our abuser/s–and not speak up for our rights–not question ‘the goings-on’ AGAINST US . . . for fear of reprisal ??!!!! I think NOT. Trust in this instance (of abuse) looks like this–The only thing that we can trust — and see evidence of — in this equation is that the MISREPRESENTATION AND ABUSE AGAINST pw ME/CFS CONTINUES–with DENIAL of BIOLOGICAL facts and state-of-the art research IN PROGRESS.

Welllll then—Let’s question the timing of this sabotaging ‘IoM’ ‘contract’–right when MUCH current research into the BIOLOGICAL disease of ME/CFS is EXPLODING with evidence of biomarkers!!! Ummmm—ya—HOW stupidly transparent can the HHS and Co. get with this . . . ?!!!!

Instead of WORKING WITH THE ME/CFS EXPERTS AND RESEARCHERS, Sebelius and the HHS Department RUSH into this concocted IoM contract to have us all declared ‘NUTS’–and throw anti-deps, CBT and GET at us–which further exacerbates the disease–or–how about seizing some of ‘em (us) up and lock ‘em up in the psyche ward! THIS IS THE UNBELIEVABLE AND MOST UNFORTUNATE REALITY that WE ARE faced with! AND–THIS IS ABHORABLE HUMAN CRUELTY AND INJUSTICE AGAINST and TOWARDS US!! AND this HUMAN CRUELTY all comes down to money–the powers that be (insurance cos., et al) do NOT want to pay out for LONG-TERM DISABILITY for ME/CFS–and resulting ‘biomarkers’ for ME/CFS are threatening to them. Our health and wellness is of NO consequence (to those corporations)–their bottom-line dollar (and pay-out) is what is dear (to the corporations).

NOOOO—this BULLYING WAR — set in motion AGAINST pw ME/CFS originating decades ago–and now seems to be ‘running’ in FULL FORCE–to DENY us QUALITY AND EFFECTIVE HEALTH CARE and a healthy and productive life for the millions of us—THIS ABUSE and MISTREATMENT of us that has been set in motion against US is NOT something that we are going to acquiesce to.

We ARE speaking up for our RIGHTS AS HUMAN BEINGS–we have that RIGHT! Something that is so BLATANTLY WRONG MUST BE RIGHTED–i.e. the GROSS MISTREATMENT and ABUSE of pw ME/CFS–and others like those with GWI! AND it is incumbent upon US pw ME/CFS, our good doctors, experts and researchers to continue to speak up and advocate for what is HUMANLY RIGHT. We have a RESPONSIBILITY to ourselves, our families, fellow patients and their families and those of the next and following generations who will become afflicted and debilitated because of the HORRID disease of ME/CFS; that ‘non-existent’ disease that has been PURPOSELY NEGLECTED and left to RUN RAMPANT–disabling millions globally!!

ME/CFS, indeed, IS a PREVALENT, DEVASTATING AND DEBILITATING BIOLOGICAL DISEASE.

As for the IoM contract–set in motion to DENY the latter–it is in essence, a $1 million ‘book review’ of evidence-based medicine–using ‘CHOSEN’ OLD OUTDATED MISINFORMATION to accomplish ‘their’ SKEWED OUTCOME and AGENDA.

Wow, what an illuminating analysis of this whole situation with HHS and IOM. Thank you Jeannette once again. All these dead on points do help to ignite some passion to not give up in this manipulation of ME patients by HHS. I also wonder what someone commented, what is the consequence of no responding to a FOIA request, if any lawyers out there know the answer.
Hope you recover quickly Jeannette!

Thanks greatly for this Jeannette, Im so glad Im not the only one who has been seeing red flag after red flag (what’s that saying .. where their is smoke there is fire)… I only wish my brain could of read the whole thing.

Maybe someone could do a very brief summary …listing all the red flags listed here as many of us just cant get throu such a long letter and unfortunately many of those who cant are the ones who least can think and work out what is going on and how they are being deceived.
(maybe its not a case of Stockholm but rather that many just cant get their heads around this whole situation. and unfortunately cant read long letters).

“Let’s question the timing of this sabotaging ‘IoM’ ‘contract’–right when MUCH current research into the BIOLOGICAL disease of ME/CFS is EXPLODING with evidence of biomarkers!”

Yes Ess, that is what I think too. ME/CFS was becoming too much of a threat so this result.

As a former communications executive and pragmatist/cynic (and as someone who has just binge-watched “Scandal” on Netflix!), I believe there is only one scenario that will produce the results we want with IOM: This story of cover-up needs to be pitched to a well-placed investigative national journalist and Jeanette should be interviewed (among others). Although Jeanette, your herculean efforts SHOULD theoretically yield us the termination of the contract, unfortunately, the media is our only effective weapon against political and corporate corruption/ineptitude.

If anyone decides to write an article such as the one Tania Selth is discussing, here is the Petition to Stop the HHS-IOM Contract and Accept the CCC Definition of M.E. It was delivered in person to Secretary Sebelius’ Office on December 10, 2013, by Susan Kreutzer. However, it is still accepting signatures and can be sent again. Today it has 3,296 signatures–and the number is increasing every day.

“We, the undersigned people suffering from Myalgic Encephalomyelitis, along with our families, carers and friends hereby ask Secretary Kathleen Sebelius to cancel the contract HHS signed with the Institute of Medicine (IOM) to develop “clinical diagnostic criteria” for ME/CFS. We further urge Secretary Sebelius to respect the consensus reached by a group of experts supporting the adoption of the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS.”

AGREED–good point, Pam, “This story of cover-up needs to be pitched to a well-placed investigative national journalist . . . ”

Info/suggestion on this (previously posted on November 20, 2013) —
Just saw on CNN a report about US veterans dying due to diagnosis delays or treatments delays @ US Veterans hospitals. A US congressman was involved–allocating more funds to help the backlog–ONLY 1/3 of the $million + was used for this–backlogs got longer in a matter of only a few months–Veterans dying.

DREW GRIFFIN was the reporter on this–hosted by Wolf Blitzer (November 19, 2013).
A parting word with this program–in general–if you ‘we’ HAVE ANYTHING TO REPORT/INVESTIGATE–contact cnn.com/investigations or DREW GRIFFIN.

THAT sounds like a great INVITATION AND OPPORTUNITY to call CNN into the ME/CFS debacle. . . ?? !!

Thanks for your support and ideas, Ess. If we were to go forward with this idea of pitching the media, it would necessitate a thoughtful discussion among lead advocates about which reporter would be the ideal target. (For example, do we target a writer who has already covered ME/CFS and has a built in understanding? Do we target The Washington Post to disarm the government in their own backyard? Do we pitch the reporter with whom one of us has a close relationship? Do we ask a favor of a PR professional with whom we have a relationship? And, of course, what is the 30-second pitch anyway?) First, we need to decide WHO is the decider to implement this idea, and then WHO will help that decider. A game-changing idea such as this warrants a leader, a team and a strategy. Any thoughts?

YUP–pitching to the media would definitely be a ‘project’ — a well thought out and well-organized project–details as you have described, Pam. All great questions and points, and as to whom would be the ideal media target–and what exactly would the 30-second pitch be, as you say. Would there just be ‘ONE’ media target or could there be more? For example, Llewellyn King has been following ME/CFS. The Washington Post–government’s own backyard–what could be better!! Anderson Cooper/CNN holds much esteem . . . I think pitching to the media IS a great idea; exposure of the cover-ups and just ‘what exactly is going on in this MOVEMENT AGAINST pw ME/CFS’ is paramount. Definitely needs the direction of the lead advocates.

You mentioned ‘Scandal’ on Netflix — then there is Water Gate . . . Erin Brockovich . . . GWI . . . ME/CFS. Interesting how the initial cover-up leads to more and more cover-ups–until we get to ‘this’ abomination–affecting and DEBILITATING MILLIONS OF ‘PEOPLE’ WORLDWIDE–AND spreading. I think this is a story DEMANDING to be told to the world. Jeannette being interviewed–FOR SURE–OTHERS, including ME/CFS Experts/Researchers.

Could patients in the US end up like Karina in Denmark?? Could patients who refuse to partake in GET and CBT end up being forced into hospital and forced on such treatments?? Its a sad situation in Denmark and should this contract be pushed through it will be a sad day for the US.

I have followed with concern the apparent replacement of the CFSAC by the IOM. As a former chair of the CFSAC, my major responsibility and concern was to arrive at appropriate recommendations by the development of an understanding of ME/CFS disease mechanism, reliable diagnostic criteria, effective treatment of symptoms and eventual prevention and cure. These goals could only be achieved through open interaction of researchers, clinicians and patient-advocate through ongoing updates using developing literature and face to face discussion of the CFSAC panel. The above interaction of the above noted groups and governmental agencies occurred in this open meeting format. When informed of the IOM panel, I signed the letter of objection while also volunteering to serve on the panel if the petition to stop the process failed. My special concern for ME/CFS is the diagnosis and treatment in children and adolescents which I thought needed to be represented on the panel as it was on the CFSAC. While not chosen, I will follow outcomes of the IOM panel, but urge that the CFSAC continue as an independent group that provide reasoned recommendations and balanced comments for improving the understanding, diagnosis and treatment of this disease. The IOM contract will not eliminate the need or purpose of the CFSAC and this panel should, in fact, evaluate the findings of the IOM in a reasoned and thoughtful manner at the first CFSAC meeting after their release.

Welllllllllllll, I have a little more to say (oooops, it got ‘longer’) as we start off the New Year 2014–with a GLORIOUS-looking sunny day out there. People are out there ‘IN THE WORLD’ moving around, enjoying and actually living their lives with all the choices open to them–and so TOO ‘ought we’ have that choice, those choices, that freedom for living and for life . . . free of DEBILITATING ‘never-ending’ ILLNESS!!!!!!!

ALAS, that ‘choice’ — that opportunity to live daily life IN ALL ASPECTS has been STOLEN from US — NOT ONLY because of ME/CFS–AS IF THAT ISN’T BAD ENOUGH–we are held HOSTAGE with/in ME/CFS and given ‘NO END IN SIGHT’ (pardon the pun on ‘END’) DUE TO the NEGLECT, MALTREATMENT–and WORSE ‘given us’ by the government and powers that be–the MOVEMENT AGAINST getting to the SCIENTIFIC answers to ME/CFS.

Doesn’t that scenario sound ABSURD; it IS–ABSOLUTELY ABSURD—YET, it is OUR MOST UNFORTUNATE REALITY!!

THAT is what this ‘FIGHT’ about STOPPING the IoM contract is all about; LED, IN FACT, by the ME/CFS Experts and Researchers in an all-out effort to GENUINELY AND INTENTLY HELP US pw ME/CFS to get to the SCIENTIFIC answers to HELP US ‘get our lives back,’ AND, IMPORTANTLY, to put a STOP to the SPREAD of ME/CFS.

We, and our families with us, are hanging on to ‘life’ as best we can under these HORRIFIC circumstances; the IoM contract has been CONCOCTED NOT to help us–the powers behind the IoM contract seek to BURY US with this SHAM!

This is all sooooo WRONG–SOOOOO VERRRRY VERRRRY WRONG . . . AND needs to be / is BEGGING to be CORRECTED!!!!

Thirty years or more–waaaay too long with this INJUSTICE and DENIAL of our RIGHTS to MEANINGFUL health care; this FOOLISH CATASTROPHIC PURPOSEFUL NEGLECT AND DISREGARD ‘now equals’ 17 million or more of US pw DEBILITATING ME/CFS globally.

Don’t you think that this ’cause’–our VERY LIVES is WORTH fighting for?? I think the answer is self-evident. This is the time to STAND UP and SPEAK UP!!

Thanks so much to Jeannette for this blog–all the most IMPORTANT work that you do as an ADVOCATE–including giving us an opportunity through your blog to join in the FIGHT FOR OUR LIVES!!!

This is excellent, Jeannette – thank you again! Couldn’t pick a favorite line, there are so many! The Hyde quote made me think of what he’s probably saying to himself as he watches U.S govt. do this yet again in his long lifetime. Reminded me of something as befitting now as it was WAAAY back. A battle cry from the past…

In his article “Americans Should Shake Up the CDC Definition and Research Committees”, Dr. Byron Hyde shows how long this very same battle – history repeating – has been going on. Here are some serious fightin’ words, which were lost from the Nightingale website after an update several years ago. (I don’t remember the date of this article, but maybe 12-15 years ago?):

“Americans Should Shake Up the CDC Definition and Research Committees”

“Have you ever reviewed the physicians and researchers on the original 1988 CDC definition and counted how many of them actually had ever seen a significant number of CFS patients or had ever previously or after published on CFS? The number is not high. This improved in the 1994 definition committee but even then you may recall that this occurred only when I got up and criticized the chair for even attempting to put out another definition without a group of hands-on US and international physicians on the committee. I think that got Dan Peterson on the list. Unfortunately the 94 definition was a rubber stamp of the 88 definition that has plagued physicians ever since. There were still too many members on that committee who simply rubber-stamped the previous group’s work.

“Name all of the serious original contributors to CFS knowledge in the past fifteen years and you may note the fact that their names are largely absent from the roster of NIH grant recipients.

“Find me a single penny of NIH funds that has gone to autopsy research and tell me how many thousands of M.E./CFS patients who have died during this period, their brains and spinal cords lost to serious research.

“Find me any serious ongoing funds dedicated by the NIH to any of the epidemic M.E./CFS situations that have occurred during the same period….”

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